Ashvini Madhav Marshivane
Bidar
Summary
Operation Specialist 1 with 5 years of experience in pharmacovigilance and regulatory compliance at IQVIA RDS PVT LTD. Proven skills in safety risk assessment and ICSR processing, resulting in better patient outcomes. Dedicated to operational excellence and elevating compliance standards through strategic collaboration.
Overview
5
5
years of professional experience
Work History
Operation Specialist 1
IQVIA RDS PVT LTD
Bangalore
09.2020 - 12.2025
- Worked as an Operation Specialist 1 ensured safety and efficacy of oncology and psychiatric products throughout lifecycle.
- Identified and mitigated potential safety risks to protect patient health and enhance outcomes.
- Executed understanding of SOPs, guidelines, and regulatory requirements including GCP and GVP to ensure compliance.
- Processed ICSRs according to regulations and project requirements, ensuring adherence to quality standards.
- Collaborated with cross-functional teams to provide high-quality support on pharmacovigilance activities.
- Conducted technical training and participated in audits to uphold compliance and operational excellence.
- Reviewed systems for enhancement opportunities to improve overall efficiency.
- Maintained relationships with stakeholders to ensure timely information exchange and support operational needs.
Education
Doctor of pharmacy - Pharmacology and Clinical Practice
Govt. College of Pharmacy
Amravati, Maharashtra01.2019
Skills
- Pharmacovigilance and compliance expertise
- ICSR processing
- Regulatory compliance
- MedDRA coding
- Adverse event reporting
- Drug labeling review
- Data entry
- Expert with LSMV and Aris G database
- Root-cause analysis
- Task prioritization
- Audit assistance
- Drug safety monitoring
- Training facilitation
- ICH guidelines
- Analytical data skills
- Medical terminology proficiency
- Detail-oriented mindset
- Communication skills
Professional Summary
With 5 years of experience in pharmacovigilance, I excelled as an operation specialist 1 and in IQVIA RDS PVT LTD Bangalore. Working operation specialist 1 specializes in as an exclusive pharmacovigilance professional, I am committed to ensuring the safety and efficacy of oncology, psychiatric, gastrointestinal and hematological etc. products, throughout their lifecycle. With expertise in regulatory compliance and risk management, I work to identify and mitigate potential safety risks ultimately protecting patients' health and enhancing outcomes. My keen interest in pharmacovigilance drives me to an evolving regulation to stay up to date with best practices, which will give an opportunity to provide high-quality support to cross-functional teams and stakeholders., Experience: 5 Years., Understanding of global pharmacovigilance regulations, such as GVP, ICH, and local regulatory requirements., Ability to process and manage individual case safety reports (ICSRs), including data entry, quality control, and follow-up., Knowledge of risk management principles and practices, including risk assessment, mitigation, and monitoring., Proficiency in managing pharmacovigilance databases, such as ARISg and LSMV., Meticulous attention to detail to ensure accurate and high-quality data entry and processing., Understanding of regulatory reporting timelines.
Technical Expertise - Components
- Understanding of ICH guidelines, such as E2B and E2C.
- Understanding of regulatory reporting requirements, including periodic safety update reports (PSURs) and adverse event (AE) reporting.
- Experience with pharmacovigilance software, such as LSMV, ARISg.
- Ability to analyze complex data and identify trends, patterns, and potential safety signals.
- Familiarity with medical terminology and pharmacological concepts.
- Knowledge of global regulatory requirements, including GVP and local regulations.
Languages
- English
- Hindi
- Kannada
- Marathi
Personal Information
- Date of Birth: 10/15/95
- Nationality: Indian
- Marital Status: Married
Job Profile
- Read, understand and implement all applicable SOPs, Working Instructions and guidelines CPD, WHO DD & MedDRA coding.
- Understand relevant safety implications regarding contracts with operating companies and/or marketing partners.
- Review and make suggestions for system and process enhancements.
- Technical training and eLearning.
- Participation in inspection and audits as required.
- Participation in local or global project teams.
- Preparation in business continuity plan as required.
- Continuous development of personal skills, whether task or competency related.
- In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GP), Good Pharmacovigilance Practice (GVP) and International Conference on Harmonization (ICH) guidelines.
- In-depth knowledge of departmental standard operating procedures (SOPs).
- Strong coaching, team building, communication and written skills.
- Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities.
- Ability to establish and maintain effective working relationships with coworkers, managers and Customers.
- Working knowledge of related safety database applications ie., LSMV and Aris G.
- Basic understanding of regulatory reporting obligations.
- Problem-solving abilities.
- Process ICSRs according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.
- Receive, review, process data from various sources on time to meet quality standards.
- Perform data entry for tracking, coding relevant medical terminology, writing descriptive narratives, generating queries pertinent to the case, performing quality review, assisting with review and reconciliation of applicable reports, driving case closure, requesting translations and ensuring ICSR are processed within assigned timelines.
- Address emails from different stakeholders and customers supporting ICSR activities within timelines and seek clarifications where appropriate (Local Safety Officer (LSO), Pharmacovigilance Physicians (PVP), Customer POCs, safety operational mail box, etc.).
- Assist operations team with tasks and be a back-up for identified activities.
- Assist in generation of status reports, achievement of productivity and utilization metrics.
- Contribute under guidance of manager to individual deliverables in the field of Safety operations or other service lines as appropriate.
- Contribute to innovation and process improvements.
- Attend project team meetings and provide feedback on any challenges/issues or successes.
- Liaise with client in relation to details on day to day processing of ICSRs.
- Ensure compliance to quality standards and work with different stakeholders and customers to achieve project and customer deliverables.
- Active participation in Subject Matter Expert (SME) and mentoring programs.
- Collaborate with management to help achieve operational departmental goals i.e. understands metrics and deliverables.
- Read and acknowledge all necessary organizational standard operating procedures (SOPs) and customer SOPs as required.
- Ensure all required training is executed in a timely fashion and documented.
- Work towards ensuring individual training plan and training transcript are reconcilable.
Disclaimer
- I hereby declare that the above-mentioned particulars are true to the best of my knowledge and belief.
Timeline
Operation Specialist 1
IQVIA RDS PVT LTD
09.2020 - 12.2025
Doctor of pharmacy - Pharmacology and Clinical Practice
Govt. College of Pharmacy